Impact of Ranolazine on Coronary Microcirculatory Resistance

University of New Mexico (UNM)

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Disease; Ischemia; Coronary Microcirculation

Treatments: Drug: Rnalozine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01815957

12-069 MICRO Study

Details and patient eligibility

About

This study is being done to determine if Ranolazine treatment improves coronary microcirculation function among patients with coronary microcirculation dysfunction. We are also looking to learn if symptomatic improvement of chest pain during treatment with Ranalozine is related to improved coronary microcirculation function.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Patients with subjective symptoms of ischemia without flow limiting angiographic CAD (<50% epicardial coronary stenosis) and abnormal IMR (>20 U).

• Definition of ischemia (any one):

  • chest pain with dynamic ischemic ECG changes (t wave inversions or > 1 mm ST depressions
  • Exercise treadmill testing induced chest pain with ≥1 mm of downsloping or flat ST segment depression during exercise or recovery; ≥2 mm of ischemic ST depression at a low workload (stage 2 or less or ≤130 beats/min); early onset (stage 1) or prolonged duration (>5 min) of ST depression; multiple leads (>5) with ST depression
  • Nuclear stress perfusion defect > 10%
  • Stress echocardiogram with stress induced wall motion abnormality

Exclusion criteria

• • Age < 18 yrs
• Flow Limiting epicardial CAD >50%
• Life expectancy < 6 months
• Recent (<1 week) myocardial infarction or positive biomarkers
• Severe aortic stenosis
• Contraindications to IMR testing including inability to utilize antithrombotic therapy and/or intravenous adenosine
• Contraindications to Ranolazine therapy:
• Patients with known hepatic insufficiency, prolonged QT or renal failure (GFR < 60)
• use of drugs that inhibit CYP3A such as diltiazem, verapamil, ketoconazole, macrolides and HIV protease inhibitors
• Pregnancy, breastfeeding
• Patients taking drugs which prolong QT interval

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Ranalozine

Experimental group

Description:

After enrollment in the study, participants will initiate Ranolazine for 4 weeks. The participant's usual anti-anginal medication regimen will be continued unchanged throughout study duration. Patients will receive Ranolazine 500 mg orally twice daily for 1 week, and the dose will be increased to 1,000 mg twice daily for an additional 3 weeks if tolerated.

Treatment:

Drug: Rnalozine